Privately-held biotech Allegro Ophthalmics said today that its Del Mar Phase IIb stage 2 trial met its primary endpoint. The study assessed Luminate as a sequential therapy or combo therapy in 80 patients with diabetic macular edema. The San Juan Capistrano, Calif.-based company’s Luminate integrin peptide therapy treats neovascular retinal diseases by targeting integrin receptors, which are […]
Mylan tumbles on Q2 miss, lowered outlook
Mylan (NSDQ:MYL) shares fell more than -6% this morning after it posted second quarter results that missed analysts’ sales and earnings estimates. The generics-maker announced that it would not include any major U.S. product launches in its forecast for the full-year, citing uncertainty in the U.S. regulatory market. Other generic drugmakers, like Teva Pharmaceuticals (NYSE:TEVA), have posted disappointing Q2 […]
Aerie’s contract manufacturer faces regulatory hurdle
Aerie Pharmaceuticals (NSDQ:AERI) said today that its contract manufacturer received a complete response letter from the FDA regarding a regulatory application for one of the manufacturer’s own product candidates. The rejection letter reportedly cites a CGMP inspection at the facility as reasoning for the CRL. The facility also manufactures Aerie’s Rhopressa ophthalmic solution, which the FDA […]
Novo Nordisk shares rise on solid Q2 results
Diabetes drugmaker Novo Nordisk (NYSE:NVO) posted Street-beating second quarter results today, lifting its full-year sales forecast despite lingering concerns relating to U.S. drug pricing pressures. Last year, the Danish company saw shares drop more than 40% after it slashed its long-term operating profit forecasts, citing price pressures in the U.S. market. Today, Novo Nordisk raised its […]
Sanofi brings another insulin glargine patent suit against Merck
Sanofi Aventis (NYSE:SNY) yesterday filed another patent lawsuit against Merck Sharp & Dohme Corp. (NYSE:MRK), alleging that Merck’s product infringes upon two patents covering Sanofi’s insulin glargine product, Lantus. In July, Merck won tentative approval for its follow-on biologic version of Sanofi’s Lantus. The agency’s final regulatory nod is contingent upon the resolution of these patent infringement suits, […]
Luminex tops Q2 estimates
Shares in Luminex (NSDQ:LMNX) rose today after the company beat expectations on Wall Street with its second quarter results. The Austin, Tx.-based company posted profits of $5.5 million, or 13¢ per share, on sales of $76.5 million for the 3 months ended June 30, for bottom-line growth of -1.9% on sales growth of 19% compared with the […]
MannKind posts mixed Q2
Shares in MannKind Corp. (NSDQ:MNKD) fell slightly this morning after the biopharmaceutical company missed earnings expectations but beat sales estimates on Wall Street with its second quarter results. The Valencia, Calif.-based company posted a net loss of -$35.4 million on sales of $2.2 million for the 3 months ended June 30, for bottom-line loss of -18% on sales growth of […]
Anika Therapeutics touts Hyalofast scaffold, stem cell combo
Anika Therapeutics (NSDQ:ANIK) touted data today from a study evaluating the use of its Hyalofast biodegradable, hyaluronic acid-based scaffold in combination with autologous adult mesenchymal stem cell therapy for cartilage lesions in the knee. The study, which was published in Knee Surgery Sports Traumatology Arthroscopy, showed that the treatment was equally effective among patients, regardless of age. […]
Mallinckrodt beats Q2 earnings, misses on revenue
Shares in Mallinckrodt Pharmaceuticals (NYSE:MNK) fell today after the company beat earnings estimates but missed on revenue with its second quarter results. The U.K.-based company posted profits of $62.8 million, or 72¢ per share, on sales of $824.5 million for the 3 months ended June 30, for bottom-line loss of -68% on sales loss of -5% compared […]
Rebiotix launches late-stage superbug trial for microbiome-based drug
Rebiotix isn’t a traditional drugmaker. Its products are alive. The 32-person company, based in Roseville, Minn., is developing a microbiome-based therapy to prevent recurrent Clostridium difficile infection. Its Microbiota Restoration Therapy, which is delivered via enema or a lyophilized, non-frozen oral capsule, is designed to supply a patient’s intestinal tract with an array of healthy, human-derived microbes. Get […]
Endo swings to Q2 loss on $775m pelvic mesh set-aside
Endo International (NSDQ:ENDP) posted a net loss in the second quarter of this year, citing charges like the $775 million it has set aside to resolve 22,000 remaining lawsuits relating to the company’s vaginal-mesh implants. The generic drugmaker faced other setbacks this quarter, including the FDA asking that Endo pull its painkiller, Opana ER, from the market. […]